Precision medicine diagnostics company Renalytix plc (LSE: RENX) (OTCQB: RNLXY) revealed on Wednesday that it has completed key regulatory and operational milestones to support the scaling of its kidneyintelX.dkd diagnostic platform, including the transfer of laboratory operations to a new facility in New York.

The state-of-the-art laboratory increases testing capacity by more than 3.5 times, enabling throughput of over 100,000 tests annually, while reducing the company's fixed cost base. The transition included full analytical validation of the kidneyintelX.dkd assay and regulatory inspection by the New York State Department of Health. Renalytix expects cost savings exceeding USD2.6m on a net present value basis over five years, supporting improved gross margins and operating leverage as volumes scale.

In parallel, the company has completed the submission of the technical file for CE marking of kidneyintelX.dkd, a key step in enabling use in global pharmaceutical clinical trials and supporting commercialisation in selected European markets. CE marking is anticipated to be finalised in Q3 2026, with initial patient testing at the Steno Diabetes Center expected in Q4 2026 and broader revenue-generating activity targeted for 2027.

kidneyintelX.dkd is currently the only FDA-approved and Medicare-reimbursed prognostic test for early-stage risk assessment in chronic kidney disease and is being deployed across physician groups and health systems in the US.